CN110461249B - System and method for influencing movement of tissue structures - Google Patents

Abstract

The present invention relates generally to medical devices and procedures for placing medical devices between adjacent tissue structures. In particular, the present invention relates to endoscopic systems and methods for preventing or minimizing movement between tissue walls to facilitate placement of a stent therebetween.

Description

Systems and methods for affecting movement of organizational structures

Cross References to Related Applications

This application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Serial No. 62/476,995, filed March 27, 2017, the entire contents of which are incorporated herein by reference for all purposes.

technical field

The present invention relates generally to the field of devices and procedures for placing medical devices between adjacent tissue structures. In particular, the present invention relates to endoscopic systems and methods for preventing or minimizing movement between tissue walls to facilitate placement of stents therebetween.

Background technique

Although endoscopic imaging modalities, such as fluoroscopy and endoscopic ultrasound (EUS), allow direct visualization of anatomical structures beyond the tissue in front of the endoscope, they cannot be controlled during endoscopic procedures (eg, stabilization, fixation, anchoring, etc.) these distal anatomies present challenges. For example, medical procedures such as gastrojejunostomy, hepatic ductogastric anastomosis, and gallbladder drainage require the placement of catheters (eg, stents, etc.) within appropriate portions of the proximal and distal tissue walls. The tendency to lose control of the distal tissue wall during a transmural stent deployment procedure presents a significant technical challenge to medical professionals, especially when direct visual images of the distal tissue wall are not available. Failure to properly position the fluid conduit within the proper portion of the tissue wall can lead to serious medical complications.

Various advantageous medical outcomes may be achieved by the systems and/or methods of the present invention that minimize or prevent movement of the proximal and distal tissue walls away from each other during a transmural stent placement procedure.

Contents of the invention

In one aspect, the invention relates to a system comprising a needle including a proximal end, a sharpened distal end and a lumen extending therebetween. The elongate member may be slidably disposed within the lumen, wherein the distal portion of the elongate member is configured in a first configuration when disposed within the lumen and a second configuration when disposed distally beyond the sharpened distal end to move between. The distal portion of the elongated member may be substantially rectilinear in the first configuration and substantially non-rectilinear in the second configuration. The second configuration may include a circle, a spiral, and a figure-eight. The distal portion is divisible along the longitudinal axis of the elongate member to define first and second branches. The first and second branches may be substantially collinear with the elongate member in the first configuration. The first and second branches may form a Y-shape, a T-shape or a W-shape in the second configuration. Alternatively, the first and second branches form a substantially spherical or elliptical structure in the second configuration.

In one aspect, the invention relates to a system comprising a needle including a proximal end, a sharpened distal end and a lumen extending therebetween. An elongated member may be slidably disposed within the lumen. The elongated member may include a control rod, and a sheath slidably disposed about the control rod, wherein the distal portion of the elongated member is configured in a first configuration when disposed within the lumen and when passed distally The sharp distal end is set when moving between the second morphologies. The distal portion of the sheath may include at least one slot formed therein, wherein the distal end of the control rod is attached to the distal end of the sheath. The distal portion of the sheath is movable from the second configuration to the first configuration by advancing the sheath distally over the lever. Alternatively, the distal portion of the sheath may be moved from the first configuration to the second configuration by proximally retracting the lever through the sheath. Alternatively, the distal portion of the sheath may be moved from the first configuration to the second configuration by advancing the sheath distally over the lever. The distal portion of the sheath is movable from the second configuration to the first configuration by distally advancing the control rod through the sheath. Alternatively, the distal portion of the sheath may be moved from the second configuration to the first configuration by retracting the sheath distally over the lever. The distal portion of the sheath may form a basket in the second configuration.

In another aspect, the invention relates to a method comprising passing a needle having a sharpened distal end and a lumen that travels from the proximal end to the distal end through the tissue wall of a first body lumen and a second body lumen adjacent to the first body lumen advancing the tissue wall of the needle, and advancing the elongate member distally through the lumen of the needle such that the distal portion of the elongate member moves to a second configuration in contact with a portion of the tissue wall of the second body lumen to affect the second body lumen Position relative to the first body cavity. The method may also include withdrawing the needle from above the elongate member and advancing the stent delivery system over the elongate member such that the distal ends of the stent delivery system form opposing holes in tissue walls of the first and second body lumens . The method may also include deploying the stent from the stent delivery system between the first and second body lumens. The method may also include distally retracting the elongate member through the stent delivery system and removing the stent delivery system.

Description of drawings

Non-limiting embodiments of the invention have been described by way of example with reference to the accompanying drawings which are schematic and not intended to be drawn to scale. In the drawings, each identical or nearly identical component that is shown is typically represented by a single numeral. For purposes of clarity, not every component is labeled in every figure, and not every component of every embodiment shown is necessary to allow one of ordinary skill in the art to understand the invention. In the attached picture:

Figures 1A-1G provide perspective views of a system in a delivered (Figure 1A) and deployed (Figures 1B-1G) configuration, according to an embodiment of the invention.

Figures 2A-2E provide perspective views of the system in the delivered (Figure 2A) and deployed (Figures 2B-2E) configurations, according to an embodiment of the present invention.

Figures 3A-3C provide perspective views of the system in the delivered (Figures 3A-3B) and deployed (Figure 3C) configurations according to one embodiment of the present invention.

4A through 4F provide perspective views of a stent deployment procedure using the system according to one embodiment of the present invention.

Figures 5A-5C provide perspective views of stent deployment using the system of Figure 2E, according to one embodiment of the present invention.

Detailed ways

The invention is not limited to the particular embodiments described. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

Although embodiments of the present invention are described with specific reference to certain procedures, such as gastrojejunostomy, the systems and methods described herein can be used to position fluid conduits in various adjacent tissue walls, organs, blood vessels, and/or between body cavities.

As used herein, the singular forms "a" and "the" are intended to include the plural forms as well, unless the context clearly dictates otherwise. It will also be understood that when used herein the term "comprises" and/or "comprises" or "includes" and/or "comprises" indicates the presence of said features, regions, steps, elements and/or components, But it does not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups.

As used herein, the term "distal" refers to the end of the device that is furthest from the medical professional when introduced into the patient, and the term "proximal" refers to the end that is closest to the medical professional when the device is introduced into the patient. one end.

In various embodiments described herein and in other embodiments, the present invention is directed to a system that prevents incisions during transmural medical procedures where direct visual imagery and/or control of the distal tissue wall is difficult or impossible to obtain. Movement between tissue walls or minimized.

Referring to FIG. 1A, in one embodiment, a system 100 of the present invention may include a tissue penetrating element 110 (e.g., a needle, etc.) including a proximal end (not shown), a sharpened distal end 114, and a sharpened distal end 114 therebetween. A cavity 116 extending between them. An elongated member 120 (eg, a track, guide wire, etc.) including a proximal end (not shown) and a distal end 124 may be slidably disposed within lumen 116 of tissue penetrating element 110 . The distal portion 125 of the elongated member 120 can be divided (eg, separated) along its longitudinal axis to define first and second branches 125a, 125b (eg, tines, forks, branches, prongs, arms, etc.). The first and second branches 125a, 125b can be substantially collinear with the longitudinal axis of the elongate member 120 when disposed within the lumen 116 of the tissue penetrating element 110 . At least distal portion 125 of elongated member 120 may comprise various shape memory materials (e.g., metals, alloys, polymers, etc.) Movement between the first configuration when within 116 and the second configuration when disposed distally beyond the pointed distal end 114 of tissue penetrating element 110 . The distal portion 125 of the elongate member 120 is not limited to two branches, but may include any number of branches (eg, three or more branches).

Referring to Figure IB, in one embodiment, the first and second branches 125a, 125b can move or deflect substantially perpendicular to the longitudinal axis of the elongated member 120 to form a "T-shape" when in the second configuration. Referring to Figure 1C, in one embodiment, the first and second branches 125a, 125b can move or deflect substantially tangentially to the longitudinal axis of the elongated member 120 to form a "Y shape" when in the second configuration. 1D, in one embodiment, the first and second branches 125a, 125b can be bent back (bent back) along/along or parallel to the longitudinal axis of the elongated member 120 when in the second configuration to Form a "W shape". Referring to FIG. 1E, in one embodiment, the first and second branches 125a, 125b can be crimped (rolled back) along/along the longitudinal axis of the elongated member 120 when in the second configuration to form opposing A substantially spherical (eg, round) shape. Referring to FIG. 1F, in one embodiment, the first and second branches 125a, 125b can be curled back along/along the longitudinal axis of the elongate member 120 when in the second configuration to form a relatively substantially elliptical ( For example, oval, elongated spherical, etc.) shape. Referring to FIG. 1G, in one embodiment, the first and second branches 125a, 125b can be curled back along/along the longitudinal axis of the elongated member 120 to form opposing substantially elliptical shapes when in the second configuration. , which are spaced (eg, separated) from the longitudinal axis of the elongated member. Although the distal portion 125 of the elongated member 120 is depicted as forming a substantially symmetrical structure, in various embodiments, the first and second branches 125a, 125b can form the second configuration or the second configuration depicted in FIGS. Any combination of other morphologies not depicted. In various embodiments, when in the second configuration, the first and second branches 125a, 125b move independently of each other (e.g., deflect, bend, twist, compression, etc.), as discussed below.

Referring to FIG. 2A, in one embodiment, a system 200 of the present invention may include a tissue penetrating element 210 (e.g., a needle, etc.) including a proximal end (not shown), a sharpened distal end 214, and a sharpened distal end 214 therebetween. A cavity 216 extending between them. An elongated member 220 (eg, a track, guide wire, etc.) including a proximal end (not shown) and a distal end 224 may be slidably disposed within lumen 216 of tissue penetrating element 210 . At least distal portion 225 of elongate member 220 may comprise various shape memory materials (e.g., metals, alloys, polymers, etc.) Movement between a first configuration when within 216 and a second configuration when positioned (advanced) distally past sharpened distal end 214 of tissue penetrating element 210 . Referring to Figure 2B, in one embodiment, the distal portion 225 of the elongated member 220 may form a "loop" or "cuff" when in the second configuration. Referring to FIG. 2C , in one embodiment, the distal portion 225 of the elongated member 220 can be bent about 180 degrees relative to the longitudinal axis of the elongated member 220 when in the second configuration to form a "Reverse Coil" or "Reverse Helix". Referring to FIG. 2D , in one embodiment, the distal portion 225 of the elongated member 220 may form a "figure of eight", a "lasso", or a "corkscrew" shape when in the second configuration. Referring to FIG. 2E , in one embodiment, when in the second configuration, the distal portion 225 of the elongated member 220 can bend to form a "crossbar" extending across the longitudinal axis of the elongated member 220 .

The various second configurations of the distal portion 125, 225 can provide a number of additional benefits to further immobilize/immobilize the distal tissue wall when the elongated member 120, 220 is retracted proximally. As a non-limiting example, the ends of the first and second prongs 125a, 125b depicted in any of FIGS. 1B-1D may be partially penetrated/embedded in the distal tissue wall. A portion of the branches 125a, 125b in any of FIGS. 1B to 1G or the distal portion 225 of the elongated member 220 of FIGS. 2B to 2E may include one or more hooks, barbs, forks, etc., to provide Enhanced friction against the inner wall of the distal tissue. In various embodiments, the branches 125a, 125b and/or the distal portion 225 of the elongated member 220 can provide a gradual increase in holding pressure as the elongated member 120, 220 is retracted proximally, allowing a medical professional to A greater or lesser fixation force is applied to the inner surface of the distal tissue wall as desired throughout the course of the medical procedure. Additionally or alternatively, a portion of the surface of the branches 125a, 125b of any of FIGS. 1B to 1D may include a sharp edge configured to enlarge or dilate to be penetrated by tissue within the first and/or second tissue wall. The puncture hole created by the sharp distal end 114 of the penetrating element 110. One or both of the spherical or elliptical shapes of FIGS. 1E-1G , respectively, can be deflected (eg, bent, expanded, etc.) away from the longitudinal axis of the elongated member 120 to provide retaining pressure on a greater surface area of distal tissue.

3A to 3C, in one embodiment, a system 300 of the present invention may include a tissue penetrating element 310 (e.g., a needle, etc.) including a proximal end (not shown), a sharpened distal end 314, and a A cavity 316 extends therebetween. Elongated member 320 may be slidably disposed within lumen 316 of tissue penetrating element 310 . Elongated member 320 may include a lever 322 slidably disposed within a sheath 326 . Distal end 324 of lever 322 may be attached to distal end 327 of sheath 326 . Distal portion 325 of sheath 326 can include one or more slits 329 formed therein and is configured in a first configuration when disposed within lumen 316 of tissue penetrating element 310 ( FIG. 3A ) and when Movement between the second configuration is disposed distally beyond the sharpened distal end 314 of the tissue penetrating element 310 (FIG. 3C).

For example, at least the distal portion 325 of the sheath 326 may comprise a variety of materials, including but not limited to shape memory materials such as Nitinol, polyetheretherketone (PEEK), etc., into which one or more slit329. Elongate member 320 may be advanced through lumen 316 of tissue penetrating element 310 by distally advancing control rod 322 ( FIG. 3B ). In one embodiment, the distal portion 325 of the sheath 326 can be moved to the second configuration by advancing the sheath 326 over/distal along the lever 322 . Alternatively, the distal portion 325 of the sheath 326 may be moved to the second configuration by retracting the lever 322 proximally through/within the sheath 326 ( FIG. 3C ). In either embodiment, the one or more slits 329 can allow the distal portion 325 to form a "basket," which includes a series of arms or petals configured to engage a distal tissue wall. In one embodiment, the distal portion 325 may include one or more hooks, barbs, prongs, etc. to achieve enhanced friction against the distal tissue wall. Although FIGS. 3A to 3C depict an embodiment in which the distal portion 325 includes five slits configured to form five arms when in the second configuration, in various embodiments the distal portion may include Any number of slots configured to form various second configurations.

In one embodiment, the elongated members 120, 220, 320 disclosed herein may be disposed within and delivered through a tissue penetrating element 110, 210, 310 comprising a A 19- or 21-gauge needle for aspiration (FNA) or fine-needle biopsy (FNB) procedures, as known in the art. Additionally or alternatively, tissue penetrating elements 110, 210, 310 and/or elongate members 120, 220, 320 may advantageously include a coating, such as a fluorinated polymer or p-xylene, to provide electrical insulation and/or Improved lubricity. To prevent coring of the proximal or distal tissue wall, the distal portion 125, 225, 325 of the elongate member 120, 220, 320 may be configured at or near the sharpened distal end of the tissue penetrating element 110, 210, 310 Cavities 116, 216, 316 are closed at 114, 214, 314.

In one embodiment, a system 100, 200, 300 of the present invention may be delivered through the working channel of an endoscope. Referring to FIG. 4A , in use and by way of example, an ultrasound endoscope 130 may be advanced through the esophagus into a first body cavity 140 (eg, the stomach). The distal end 132 of the endoscope 130 may include a camera 137 , a light source 138 and an ultrasound transducer 139 . Using direct view (e.g., light source 138 and camera 137), distal end 132 of endoscope 130 can be positioned adjacent to tissue wall 142 (e.g., proximal tissue wall) of first body lumen 140, which is located at second Adjacent to a tissue wall 152 (eg, distal tissue wall) of a body lumen 150 (eg, duodenum or jejunum). The second body cavity 150 can then be imaged through the first tissue wall 142 by switching the endoscope 130 from a direct view to an ultrasound view (eg, turning off the light source 138 and turning on the ultrasound transducer 139 ). System 100 may then be advanced through working channel 136 of endoscope 130 such that sharpened distal end 114 of tissue penetrating element 110 penetrates first and second tissue walls 142 , 152 and extends into second body lumen 150 .

Referring to FIG. 4B , elongate member 120 may be advanced distally past the sharpened distal end of the tissue penetrating element such that distal portion 125 moves within second body lumen 150 to the second configuration. The tissue penetrating element may then be removed (eg, withdrawn proximally) along/on the elongated member 120 through the working channel 136 of the endoscope 130 . The elongate member 120 can then be retracted proximally to place the distal portion 125 in contact with the interior of the second distal tissue wall 152 with sufficient force to minimize or prevent (e.g., anchor) the distal tissue Movement of wall 162 relative to proximal tissue wall 152 .

Referring to FIG. 4C , with the proximal and distal tissue walls 142 , 152 sufficiently secured with respect to each other, the stent delivery system 160 with the stent 162 loaded thereon may be advanced through the working channel 136 of the endoscope 130 . Stent delivery system 160 may include lumen 166 configured to slide over/along elongate member 120 . The distal end of the stent delivery system 160 may include a cutting element, such as an electrocautery surface, configured to create opposing openings (eg, holes) through the first and second tissue walls 142 , 152 . In one embodiment, the distal portion 125 of the elongated member 120 can provide a firm/stable platform against which the electrocautery surface of the stent delivery system 160 can be pressed when the opposing opening is formed. The distal portion 125 may provide the added benefit of establishing separation between the opposing tissue wall of the second body lumen 150 and the stent delivery system to prevent accidental cutting by the cutting element. In one embodiment, one (or both) of the elliptical portions of distal portion 125 can be deflected away from the longitudinal axis of elongate member 120 to provide holding pressure on a greater surface area of the distal tissue wall. Additionally or alternatively, the ability of the distal portion 125 to deflect away from the longitudinal axis of the elongate member 120 may provide space to allow: 1) the cutting element of the delivery system 160 to fully penetrate the second body lumen 150, 2) the stent 162 (FIG. 4D ) unobstructed deployment of the distal flange 166, and/or 3) introducing additional cutting elements to further dilate (e.g., enlarge) the tissue opening without exerting excessive pressure on the opposing tissue wall of the second body lumen 150 force. Additionally, the oval shape can provide a degree of flexibility to the distal portion such that the stent delivery system 160 can be advanced a sufficient distance into the second body lumen 150 to deploy the distal flange without further pushing the distal portion 125 rests against the opposing tissue wall. The distal portion 125 of the elongated member 120 may include a soft and/or compliant surface or coating to prevent trauma to the opposing tissue wall in the event of contact therebetween.

Referring to FIG. 4D , the exterior of stent delivery system 160 may then be retracted proximally along lumen 166 , elongated member 120 , and stent 162 to deploy distal flange 165 of stent 162 within second body lumen 150 . Referring to FIG. 4E , the exterior of stent delivery system 160 may be retracted further along lumen 166 , elongated member 120 , and stent 162 to deploy proximal flange 164 of stent 162 within first body lumen 140 . 4F, with the proximal and distal flanges 164, 165 properly deployed within the first and second body lumens 140, 150, the elongate member 120 can be retracted proximally with sufficient force such that the distal Side portion 125 is moved from the second configuration to the first configuration for removal through lumen 166 of the stent delivery system. Endoscope 130, stent delivery system 160, and elongate member 120 may then be removed from the patient. The stent configurations depicted in Figures 4D to 4F are provided as non-limiting examples and can include a variety of different shapes, morphologies, orientations, sizes and/or materials needed to provide a flow path between adjacent tissue walls . Additionally, the outer and/or inner surfaces of the stent may be fully or partially covered (eg, across the saddle region between the proximal and distal flanges) to prevent fluid leakage between the tissue walls. Although FIGS. 4E to 4F depict a gap between the tissue walls of the first and second body lumens 140, 150 after placement of the stent, in other embodiments, the procedure may result in the tissue walls being juxtaposed into contact with each other along the saddle region. , wherein the proximal and distal flanges provide contact with the corresponding inner surface of each tissue wall.

Although the systems 100, 200, 300 disclosed herein are configured to minimize or prevent proximal and distal tissue walls from moving away from each other during a medical procedure, rather than moving either tissue wall toward the other, in one embodiment , the elongate member 120, 220, 320 can be retracted proximally with sufficient force such that the distal portion 125, 225, 325 pulls the distal tissue wall over the stent delivery system 160 to deploy within the second body lumen 150 Distal flange.

5A to 5C, in one embodiment, the distal portion 225 of the elongated member 220 of FIG. (eg, height) and a third dimension D3 (eg, thickness). As a non-limiting example, the first dimension D1 may be about 1.00 inches, the second dimension D2 may be about 0.78 inches, and the third dimension D3 may be about 0.33 inches. In various embodiments, the first, second, and third dimensions D1-D3 of the distal portion 225 can provide a space within which the distal flange 165 of the stent 162 can be deployed (eg, within a second body lumen). , as outlined above), while the distal portion 225 of the elongated member remains in contact with the tissue wall of the second body lumen throughout the stent deployment procedure.

In various embodiments, the elongate members 120, 220, 320 disclosed herein may comprise sufficient flexibility and strength to repeatedly slide in and out of tissue penetrating elements or other medical devices (e.g., retraction catheters, etc.), while Without causing damage/rupture while maintaining the ability to move to the second configuration within the second body lumen (eg, to provide the necessary retention strength). Additionally, any of the elongate members 120, 220, 320 disclosed herein may include suitable coatings to facilitate slidable movement within a tissue penetrating element or other medical device. In various embodiments, such a coating may also impart dielectric strength to all or a portion of the elongated member.

The medical devices of the present invention are not limited to endoscopes, and may include a variety of medical devices for accessing the body, including, for example, catheters, bronchoscopes, ureteroscopes, duodenoscopes, colonoscopes, arthroscopes, cystoscopes , Hysteroscopy, etc. Finally, while embodiments of the present invention have been described as being used with an endoscope, the system of the present invention may be positioned within a patient's body in the absence of an accompanying medical device.

All of the apparatus and/or methods disclosed and claimed herein can be fabricated and performed without undue experimentation in accordance with the present invention. Although the device and method of the present invention have been described with preferred embodiments, it will be apparent to those skilled in the art that the device and/or Methods and Variations are imposed in the steps of the methods described herein or in the sequence of steps. All such similar substitutes and modifications apparent to those skilled in the art are deemed to be within the spirit, scope and concept of the invention as defined by the appended claims.

Claims (15)

1. A system for affecting movement of a tissue structure, comprising:

a needle, the needle comprising:

a proximal end, a distal end, and a proximal end,

a sharp distal end, and

a cavity extending therebetween; and

an elongate member slidably disposed within the lumen, wherein a distal portion of the elongate member is configured to move between a first configuration when disposed within the lumen and a second configuration when disposed distally past the sharpened distal end,

wherein the distal portion is configured to contact an interior of a distal tissue wall of a body lumen in the second configuration to further immobilize the distal tissue wall upon proximal retraction of the elongate member, thereby minimizing or preventing movement of the distal tissue wall relative to a proximal tissue wall of the body lumen.

2. The system of claim 1, wherein the distal portion of the elongated member is substantially linear in the first configuration.

3. The system of claim 1, wherein the distal portion of the elongated member is substantially non-linear in the second configuration.

4. The system of claim 1, wherein the second form is selected from the group consisting of toroidal, helical, and figure 8.

5. The system of claim 1, wherein the distal portion is split along a longitudinal axis of the elongated member to define first and second branches.

6. The system of claim 5, wherein the first and second branches are substantially collinear with the elongate member in the first configuration.

7. The system of claim 5, wherein in the second configuration the first and second branches form a Y-shape.

8. The system of claim 5, wherein in the second configuration the first and second branches form a T-shape.

9. The system of claim 5, wherein in the second configuration the first and second branches form a W-shape.

10. The system of claim 5, wherein in the second configuration the first and second branches form a substantially spherical structure.

11. The system of claim 5, wherein in the second configuration the first and second branches form a substantially elliptical structure.

12. The system of claim 1, wherein the elongated member comprises:

a control lever; and

a sheath slidably disposed about the control rod,

wherein a distal portion of the sheath includes at least one longitudinal slit formed therein, an

Wherein the distal end of the control rod is attached to the distal end of the sheath.

13. The system of claim 12, wherein the distal portion of the sheath moves between a first configuration when disposed within the lumen and a second configuration when disposed distally past the sharp distal end.

14. The system of claim 13, wherein the distal portion of the sheath is moved from the second configuration to the first configuration by advancing the sheath distally relative to the control rod.

15. The system of claim 12, wherein the distal portion of the sheath is moved from a first configuration to a second configuration by proximally retracting the control rod relative to the sheath.

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